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Notices of publication and a consolidated list for designated standards for active implantable medical devices.
The Medicines and Healthcare products Regulatory Agency (MHRA) has designated two new UK Approved Bodies, delivering increased capacity for the certification of the performance and safety of medical devices, for healthcare professionals and the public.
Information about core IT platforms and devices used.
FOI about the use of personal devices for work activities
Mobile device usage and hardware.
Product recall for counterfeit anti-choking devices sold via Amazon, eBay, AliExpress, Alibaba, Fruugo, OnBuy, Facebook Marketplace and DesertCart presenting a risk of choking.
We are seeking your views on the design, development, evaluation and use of medical devices.
Check the legal requirements you need to meet before you can place a medical device on the market and see how MHRA monitors compliance.
MHRA seeks views on possible amendments to the Medical Devices Regulations 2002 to include common specification requirements for manufacturers of IVD devices.
Guidance for manufacturers on the regulations that apply to prosthetic, orthotic and ophthalmic devices.
Information on road traffic devices, such as breath-testing, speed cameras and immobilisation devices.
How to distinguish between products that are regulated as medical devices and those regulated as medicinal products.
The MHRA was alerted by Beyond Compliance and the UK National Joint Registry (NJR) to a significantly higher revision rate observed with the ORIGIN PS patient-matched total knee replacement.
Information on MHRA's enforcement duties and how to report a non-compliant medical device.
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